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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579342
Other study ID # 2018/411-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2018
Est. completion date May 15, 2019

Study information

Verified date August 2019
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate if modern technology such as smartphone applications can be used to facilitate lifestyle changes and thereby improve health-related quality of life in gainfully employed persons in the general population in Stockholm, Sweden. The hypothesis is that at follow-up, the intervention group that use the new application will have improved health-related quality of life and other lifestyle habits including diet, physical activity and sleep, as well as biomarkers, compared to a control group.


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date May 15, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- Ability to communicate in Swedish

- Have access to and use a smartphone

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
App-technology and active coaching to improve lifestyles behaviors
Access to the smartphone-app during 12 weeks. A personal health goal related to for example diet, physical activity or stress habits, is set together with a heath coach. Participants receive continuous coaching every 4 weeks during follow-up.
App-technology to improve lifestyle behaviors
Access to the smartphone-app during 12 weeks. A personal health goal related to for example diet, physical activity or stress habits, is set together with a heath coach. Participants receive continuous coaching every 4 weeks during follow-up.

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm Select One...

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Research Institutes of Sweden (RISE)

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in dietary habits Intake of macro- and Micro nutrients are assessed based on responses to a food frequency questionnaire Baseline (week 0) and at 12-weeks follow-up
Other Change in eating behaviors according to the Three Factor Eating Questionnaire (TFEQ) Emotional eating, uncontrolled eating, and cognitive restricted eating are assessed using a 21-item questionnaire Baseline (week 0) and at 12-weeks follow-up
Other Change in tobacco use (user/non-user) Smoking and Swedish snuff use Baseline (week 0) and at 12-weeks follow-up
Other Change in sleeping habits Assessed using a modified 13-item Karolinska Sleep questionnaire Baseline (week 0) and at 12-weeks follow-up
Other Change in perceived Purpose In Life (PIL) 6-item questionnaire Baseline (week 0) and at 12-weeks follow-up
Other Change in perceived stress levels Assessed using the 14-item perceived stress scale (PSS) Baseline (week 0) and at 12-weeks follow-up
Other Change in motivation to make lifestyle changes Assessed using Prochaskas' transtheoretical model of behavior change Baseline (week 0) and at 12-weeks follow-up
Other Social support for an overall healthy lifestyle Social support for maintenance of a healthy Lifestyle from family, friends and co-workers is assessed by a 5-item questionnaire Baseline (week 0)
Other Change in self-reported sitting time and physical activity Assessed by 6 questions on sitting time and exercise Baseline (week 0) and at 12-weeks follow-up
Primary Health related quality of life assessed by the RAND-36 questionnaire Mental and Physical Health Scores (range 0-100) are assessed using 36 questions 12-weeks follow-up
Secondary Physical activity Minutes per day spent on a sedentary, light, moderate or higher activity level assessed using accelerometers Baseline (week 0) and at 12-weeks follow-up
Secondary HbA1c (Heamoglobin A1c) mmol/mol Baseline (week 0) and at 12-weeks follow-up
Secondary Total cholesterol (mmol/L) Baseline (week 0) and at 12-weeks follow-up
Secondary Apolipoprotein A1 (g/l) Baseline (week 0) and at 12-weeks follow-up
Secondary Apolipoprotein B (g/l) Baseline (week 0) and at 12-weeks follow-up
Secondary Body Mass Index (kg/m2) Baseline (week 0) and at 12-weeks follow-up
Secondary Body weight (kg) Baseline (week 0) and at 12-weeks follow-up
Secondary Waist circumference (cm) Baseline (week 0) and at 12-weeks follow-up
Secondary Body composition (%Body Fat) Baseline (week 0) and at 12-weeks follow-up
Secondary Blood pressure (Systolic and Diastolic) (mmHg) Baseline (week 0) and at 12-weeks follow-up
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